Roxicodone 15, 30 mg

INDICATIONS

ROXICODONE® tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioidanalgesic is appropriate.

DOSAGE AND ADMINISTRATION

ROXICODONE® is intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.

Patients who have not been receiving opioid analgesics should be started on
ROXICODONE® in a dosing range of 5 to 15 mg every 4 to 6 hours as needed
for pain. The dose should be titrated based upon the individual patient's response
to their initial dose of ROXICODONE®. Patients with chronic pain should
have their dosage given on an around-the-clock basis to prevent the reoccurrence
of pain rather than treating the pain after it has occurred. This dose can then
be adjusted to an acceptable level of analgesia taking into account side effects
experienced by the patient.

For control of severe chronic pain, ROXICODONE® should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.

As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of ROXICODONE®, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.

When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of ROXICODONE® in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose ROXICODONE® should be based upon the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.

Patients Currently on Opioid Therapy

If a patient has been receiving opioid-containing medications prior to taking ROXICODONE®, the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone.

In converting patients from other opioids to ROXICODONE® close observation and adjustment of dosage based upon the patient's response to ROXICODONE® is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of ROXICODONE® may be necessary, especially in patients who have disease states that are changing rapidly.

Maintenance of Therapy

Continual re-evaluation of the patient receiving ROXICODONE® is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be reassessed as appropriate.

Cessation of Therapy

When a patient no longer requires therapy with ROXICODONE® or other opioid
analgesics for the treatment of their pain, it is important that therapy be
gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25%
to 50% per day with careful monitoring for signs and symptoms of withdrawal
(see Drug Abuse and Dependence section for
description of the signs and symptoms of withdrawal). If the patient develops
these signs or symptoms, the dose should be raised to the previous level and
titrated down more slowly, either by increasing the interval between decreases,
decreasing the amount of change in dose, or both. It is not known at what dose
of ROXICODONE® that treatment may be discontinued without risk of the opioid
abstinence syndrome.

HOW SUPPLIED

ROXICODONE® (oxycodone hydrochloride tablets, USP) are available as
follows: